Mindray DS USA, Inc. dba Mindray North America recalls TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road…

Recall date

September 8, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0321-2017

FDA classification

Class II

Brand / firm

Mindray DS USA, Inc. dba Mindray North America

Sold / distributed

US and Canada

Why it was recalled

Mindray has become aware that the TD60 Display Telemetry Transmitter used with the BeneVision Central Station may crack on the bezel surrounding the display and also the transmitter may not power on or will power on but display an error message.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China